Cleared Traditional

Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)

K242151 · Shenzhen Nuon Medical Equipment Co., Ltd. · General & Plastic Surgery

Apr 2025

Decision

259d

Days

Class 2

Risk

About This 510(k) Submission

K242151 is an FDA 510(k) clearance for the Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B), a Light Based Over The Counter Wrinkle Reduction (Class II — Special Controls, product code OHS), submitted by Shenzhen Nuon Medical Equipment Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 8, 2025, 259 days after receiving the submission on July 23, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K242151 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 23, 2024
Decision Date	April 08, 2025
Days to Decision	259 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OHS — Light Based Over The Counter Wrinkle Reduction
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4810
Definition	Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided.